The regulations in this part apply to grants under the Clinical Cancer Education Program authorized by section 404(a)(4) of the Public Health Service Act, to encourage planning and development of multidisciplinary educational programs aimed at achieving optimal care of cancer patients and to enable students in the health professions to acquire basic knowledge of neoplastic disease and the preventive measures and diagnostic and therapeutic skills necessary to the provision of such care.

(a) Act means the Public Health Service Act, as amended.

(b) Director, NCI, means the Director of the National Cancer Institute and any other officer or employee of said Institute to whom the authority involved has been delegated.

(c) [Reserved]

(d) Board means the National Cancer Advisory Board established by section 407 of the Act (42 U.S.C. 286b).

(e) Affiliated teaching hospital means a hospital which, although not owned by such school, has a written agreement with a school of medicine, osteopathy, dentistry, or public health eligible for assistance under this part, providing for effective control by the school of the teaching in the hospital.

(f) Specialized cancer institute means an institution which has as its primary mission the diagnosis, prevention, or treatment of cancer.

To be eligible for a grant under this part, an applicant must be:

(a) A public or private school of medicine, osteopathy, dentistry, or public health, affiliated teaching hospital, or specialized cancer institute; and

(b) Located in a State, the District of Columbia, Puerto Rico, the Virgin Islands, the Canal Zone, Guam, American Samoa, or the Trust Territory of the Pacific Islands.

(a) Application for a grant under this subpart shall be made on an authorized form. 1 Applicants shall submit completed forms, on or before the dates the Director, NCI, may prescribe.

(b) [Reserved]

(c) In addition to any other pertinent information that the Director, NCI, may require, each application shall set forth in detail:

(1) A program plan defining the objectives of the proposed program and the means by which these objectives would be achieved, including descriptions of:

(i) The general educational level (e.g., pre-doctoral, post-doctoral) of the students to be involved in the program;

(ii) The proposed course of study and its relation to the diagnosis, prevention, control, and treatment of cancer;

(iii) The clinical experiences to be provided to the students;

(iv) Multidisciplinary aspects of the program;

(v) The particular schools or branches within the institution which would have responsibility for individual aspects of the program; and

(vi) The teaching mechanisms to be employed, including specific discussion of those techniques which would be innovative.

(2) The availability of personnel, facilities, and resources needed to carry out the program;

(3) The names, qualifications, and proposed duties of the program director and any staff members who would be responsible for the program, including a description of those duties which would actually be carried out by the program director and those which would be shared with or assigned to others;

(4) The names and qualifications of proposed members of a cancer education committee which would be established by the applicant to advise it on the planning, organization, operation and evaluation of the program and the specific duties which would be assigned to said committee;

(5) Insofar as necessary, cooperative arrangements with other schools, hospitals, and institutions which would participate in the program;

(6) The proposed project period, a detailed budget for the first budget period including a list of other anticipated sources of support and anticipated total needs for each of the succeeding budget periods of the requested project period, and a justification for the amount of grant funds requested;

(7) Proposed methods for monitoring and evaluating the program; and

(8) A description of how the education and training effort will be sustained upon expiration of the award.

(a) If the program is to be offered at the graduate level, it must be multidisciplinary in scope involving at least two or more clinical or preclinical sciences relating to cancer;

(b) The cancer education committee provided for in the approved application must meet at least four times per year, and must be chaired by the program director.

(a) Within the limits of funds available, after consultation with the Board, the Director, NCI, may award grants to applicants with proposed programs which in the NCI Director's judgment best promote the purposes of this part, taking into consideration among other pertinent factors:

(1) The relevance of the proposed program to the objectives of this part;

(2) The extent to which the program would involve innovative teaching techniques;

(3) The availability of adequate staff, facilities, and resources (including where necessary cooperative arrangements with other institutions or hospitals) to carry out the program;

(4) The qualifications and experience of the program director;

(5) The authority of the program director to ensure that the program is planned with multidisciplinary input and that multidisciplinary aspects of the program are carried out;

(6) The extent to which the cancer education committee is broadly representative of the disciplines concerned with cancer care and teaching and is allowed to participate in the planning, organization, operation, and evaluation of the program;

(7) If the program is to be offered at the pre-doctoral level, the extent to which its objectives are designed to aid students:

(i) To acquire a basic understanding of fundamental principles of cancer biology, epidemiology, detection, diagnosis, prevention, treatment and control;

(ii) To interest students in learning more about cancer; and

(iii) To develop an appreciation of the need for a comprehensive multidisciplinary approach to the care of cancer patients;

(8) The administrative and managerial capability of the applicant;

(9) The reasonableness of the proposed budget in relation to the proposed program;

(10) The adequacy of the methods for monitoring and evaluating the program on a continuing basis; and

(11) The degree to which the application adequately provides for the requirements set forth in § 52d.5.

(b) The notice of grant award specifies how long HHS intends to support the program without requiring the program to recompete for funds. This period, called the project period, will usually be for 1-5 years.

(c) Generally, the grant will initially be for one year and subsequent continuation awards will also be for one year at a time. A grantee must submit a separate application to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of such awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require a determination by HHS that continued funding is in the best interest of the government.

(d) Neither the approval of any application nor the award of any grant commits or obligates the United States in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.

(a) Any funds granted pursuant to this part shall be expended solely for the purposes for which the funds were granted in accordance with the approved application and budget, the regulations of this part, the terms and conditions of the awards, and the applicable cost principles prescribed by 45 CFR part 75, subpart E, except that grant funds may not be used for costs incurred in connection with activities which, prior to the grant, were part of the grantee's standard curriculum.

(b) The Director, NCI, may permit unobligated grant funds remaining in the grant account at the close of a budget period to be carried forward for obligation during a subsequent budget period, provided a continuation award is made for that period and the NCI Director's written approval is obtained. The amount of any subsequent award will take into consideration unobligated grant funds remaining in the grant account.

Several other regulations apply to grants under this subpart. These include, but are not limited to:

The Director, NCI, may with respect to any grant award impose additional conditions prior to or at the time of any award when in the NCI Director's judgment those conditions are necessary to assure or protect advancement of the approved program, the interests of the public health, or the conservation of grant funds.